Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 6:59 PM
Study NCT ID:
NCT00622232
Status:
UNKNOWN
Last Update Posted:
2011-06-08
First Post:
2008-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial
Sponsor:
VIRxSYS Corporation
Organization:
Study Overview
Official Title:
A Rollover Study to Evaluate Safety and Therapeutic Effect of Re-infusing Subjects Who Completed Participation in the VRX496-USA-05-002 Trial With Autologous T Cells Transduced With VRX496
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Rollover
Brief Summary:
The objective of this study is to determine the long term safety and tolerability of an additional infusion of 10 billion VRX496 gene-modified CD4 T cells with a focus on evaluating additional therapeutic benefits with respect to viral load and CD4 counts.
Detailed Description:
The study has concluded it's 9-month active phase. Subjects are currently in a 15-year Long Term Follow-up Phase of the study.
In keeping with the recently released Guidance on Monitoring For Delayed Adverse Events, that states that for the first 5 years all subjects should undergo monitoring of vector sequences every 6 months, subjects will visit the clinic at a maximum of 6 months intervals for a blood test evaluating persistence of vector sequences.
Therefore for the first 5 years, subjects will have 6 months visits for safety assessment. For years 6 to 15, subjects will be contacted by phone or mail. At these contacts, subjects will be asked about their health status.
In keeping with the recently released Guidance on Monitoring For Delayed Adverse Events, that states that for the first 5 years all subjects should undergo monitoring of vector sequences every 6 months, subjects will visit the clinic at a maximum of 6 months intervals for a blood test evaluating persistence of vector sequences.
Therefore for the first 5 years, subjects will have 6 months visits for safety assessment. For years 6 to 15, subjects will be contacted by phone or mail. At these contacts, subjects will be asked about their health status.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: